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Recruiting NCT07545590

A Study of Eltrekibart (LY3041658) in Healthy Participants

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY3041658, LY3041658.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Open-Label, Single Dose Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Formulations of Eltrekibart in Healthy Participants

Overview

The main purpose of this study is to evaluate how eltrekibart is absorbed by the body when it is given under the skin to healthy participants. The study will last about 17 weeks.

Interventions

  • Drug LY3041658
    Administered SC
  • Drug LY3041658
    Administered IV

Primary outcome measures

  • Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658 [Time frame: Predose on Day 1 up to Day 85]
  • PK: Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3041658 [Time frame: Predose on Day 1 up to Day 85]
  • PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration AUC(0-tlast) of LY3041658 [Time frame: Predose on Day 1 up to Day 85]

Eligibility criteria

Inclusion criteria

  • Are overtly healthy as determined by medical evaluation including medical history and physical examination
  • Have a minimum body weight of 45 kilograms (kg).
  • Have a body mass index (BMI) within the range of 18.5 to 28.5 kilograms per square meter (kg/m²), inclusive

Exclusion criteria

  • Have multiple severe allergies to prescription or nonprescription drugs
  • Are immunocompromised
  • Have had any of the following types of infection within 3 months prior to the screening visit:
  • Serious, that is, requiring hospitalization, or intravenous or equivalent oral antibiotic treatment
  • Opportunistic infections Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over
  • Chronic, that is, duration of symptoms, signs, or treatment of 6 weeks or longer, or
  • Recurring, including, but not limited to:
  • herpes simplex,
  • herpes zoster,
  • recurring cellulitis, or
  • chronic osteomyelitis.
  • Are currently pregnant or are intending to become pregnant or to breastfeed at any time in the study or within 16 weeks after receiving the single dose of study intervention.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Singapore · 1 center
  • Lilly Centre for Clinical Pharmacology — Singapore

Identifiers

NCT: NCT07545590 · 27485 · I7P-MC-DSAI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗